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A fellow patent attorney (who wishes to remain anonymous) called my attention to a recent decision issued by Judge Sue L. Robinson of the Delaware District Court.I’m not a district court decision junkie: since most patent cases revolve, at least in part, around claim construction, and since under Cybor the Federal Circuit reviews claim construction de novo, I tend to ignore many district court decisions – why bother getting into a claim construction-based case before the Federal Circuit has had its say on claim construction?This case, however, Cancer Research Technology, et al. v Barr Laboraties et al. (really Schering v Barr) dealt with the question of prosecution history laches and inequitable conduct.The i.c. part is primarily of interest to people practicing in the pharma and biotech fields, where patent applications are usually filed before extensive laboratory and clinical testing of compounds has been carried out.The laches part is of greater general interest, although less so under the 20-years-from-filing regime.

At issue was US 5,260,291, directed to tetrazine derivatives and their use in treating various cancers.The patent covers the compound temozolomide, which Schering markets under the name Temodar® for the treatment of two types of brain cancers, glioblastoma multiforme and refractory anaplastic astrocytoma.As explained in the ruling, the story started in the early 1980’s, when some researchers at Alston University in England developed some tetrazine derivatives and, in conjunction with UK pharmaceutical company May & Baker, began testing these for use against various cancers.A priority application was filed in England in 1981; a US application, 06/410656, claiming priority to the UK application was filed in 1982.

A first OA was mailed November 18, 1983, in which the Examiner rejected the application for lack of utility, asserting (on the basis of an MPEP section that has long since been supplanted) that it was necessary for the application to include data showing efficacy of the compounds in humans, but that the application lacked such data.Rather than file a substantive response, the applicants filed a continuation on March 6, 1984 and let the parent case go abandoned.In October 1984 the same examiner made the same rejection against the continuation application, and again, the applicants didn’t respond, but instead filed another continuation and let the parent case go abandoned.

Although at various points in time the representatives before the USPTO changed, this pattern of rejection-for-lack-of-utility followed by non-response-file-a-continuation repeated itself.Again.

And again.

And again.

And again.

All in all, over the course of ten years, the applicant filed ten continuations before it filed a substantive response to the lack-of-utility rejection, in February 1993.And what was the substance of that substantive response?That according to a 1986 BPAI decision, Ex Parte Krepelka, the applicants didn’t need to provide data showing efficacy in humans, and the animal test data already present in the application was sufficient.In response, the examiner mailed a Notice of Allowability, and pointed to a 1987 journal article by one of the inventors that showed that some of the compounds were active against tumors in mice as further evidence of utility.

The ‘291 patent issued in November 1993, 11 years after the first application in the chain had originally been filed, entitled to 17 years of term from grant.It then lay dormant until 2007, when Barr filed an ANDA and CRT/Schering sued.

At trial Barr stipulated to infringement of the asserted claims, but argued that the patent should be unenforceable due to prosecution history laches, i.e. unreasonable delay in prosecution by the applicants.Judge Robinson accepted this argument, in the process rejecting CRT’s assertion that it hadn’t substantively responded because the examiners required human trial data, which was unavailable.Judge Robinson ruled that not only was there no explanation given for the delay, but that the response actually filed in 1993 was based on a 1986 BPAI decision which itself invoked a 1969 CCPA decision.Thus much earlier in prosecution, the applicants could have presented plausible arguments asserting that human test data was unnecessary, and at least made a reasonable attempt to advance prosecution of the case.From the evidence adduced at trial, the only reason apparent to Judge Robinson for the prolonged delay was to enable CRT to find a strategic partner with which to commercialize the invention.That was not a good enough reason.Thus, said the Judge, the patent is unenforceable for prosecution laches.

The groundbreaking part of the decision dealt with the question of intervening rights.In previous cases of prosecution laches, the defendants had relied on the long delay in prosecution – at a time when US patent applications were kept secret until they actually issued – to develop a business; in the words of the case law, the defendants had “intervening rights”.CRT/Schering argued that Barr (nor anyone else) had developed such intervening rights here, and therefore Barr was not entitled to the relief sought.Judge Robinson disagreed: the seminal CAFC cases dealing with prosecution laches, the 2002 and 2005 Symbol Technologies v Lemelson cases, did not impose a requirement for intervening rights to exist in order for a patentee to be guilty of prosecution laches.Put differently, laches is wholly dependent on the applicant, and has nothing to do with whether or not third parties are in fact adversely affected by the applicant’s delaying tactics.

If upheld on appeal, this aspect of the decision could have adverse effects for parties with patents that issued on pre-June 1995 applications and that are thus still in force.In principle it could also affect patents filed after June 1995, although presumably the fact that it was known to the applicants that those patents would be subject to a 20-years-from-earliest-filing term induced them to avoid delaying the grant of their patents.

With regard to inequitable conduct, the decision doesn’t break new ground, but it does serve as a reminder to practitioners in the life sciences to be in touch with the inventors through prosecution and continually remind them of their duty to disclose relevant information – and not necessarily just prior art.The issue here was that the application specifically identified and claimed about a dozen compounds as being “particularly active” against lymphomas and leukemia, and described those compounds as being “important individual compounds” of the disclosed genus, and even describing three of them as being “of particular importance”.

The rub was that research by at least one of the inventors in the late 1980’s, while the application was still being kept alive at the USPTO, showed that, in fact, some of those compounds weren’t active.Such inactivity per se wouldn’t have been fatal, had the applicants then scaled back the scope of the claims to cover only the active compounds.But they didn’t: they pressed on with the broad claims and claims on the now-known-to-be-inactive compounds.Which meant that the data showing inactivity was highly material to patentability: when an examiner says your claims lack utility, and you have data that shows he’s right, that data is going to be of interest to him.

Turning to the second prong of the i.c. inquiry, intent to deceive the USPTO, Judge Robinson inferred this on the part of the inventor on the basis of the fact that during prosecution of the patent he had published more than 40 papers on tetrazine derivatives, including papers showing the inactivity of some of the compounds, yet didn’t see fit to provide this information directly the USPTO.She also noted that one of the attorneys involved in prosecuting the case testified that he would have explained to the inventors their duty to disclose, and that in any event the inventor had signed a declaration stating that he was aware of the disclosure requirement.

Having found both high materiality and intent, the finding of i.e. was inevitable.Whether or not this part of the decision will hold up on appeal will hinge in no small part on the CAFC judges assigned to the case.Reading the district court decision, it’s not clear that the inventor intended to deceive the USPTO.There were several changes of attorneys during the long prosecution of the ‘291 patent, both in the U.S. and in England, and it seems likely that the inventor may not have know that patent prosecution was ongoing and even if he did, that he didn’t realize he had a duty to disclose the negative test results to the USPTO.

Irrespective of how the CAFC holds on the inequitable conduct question, it’s clear that practitioners need to stay in contact with the inventors during prosecution, advising them that if newly-gathered data impacts the patentability of the pending claims (e.g. shows that the claimed invention lacks utility, at least across its full breadth), that information may need to be reported to the USPTO.Then again, more often than not, negative data developed along the way leads to an abandonment of the application or diminution of the scope of the claims, so not it’s not clear that facts analogous to those of the present case will repeat themselves anytime soon.

January 19, 2010

Although in the past I’ve suggested that Israel move to an early publication system, I’m neither the first nor the only person to make this suggestion.It seems that the great minds at the Justice Ministry (which would better be called the Law Ministry, but that’s for a different post) have been thinking about this for a few years as well, and have now circulated proposed amendments to the statute to deal with the matter; the proposed amendments (in Hebrew) can be downloaded here.(Most legislation in Israel emanates from the bureaucrats at the Justice Ministry, and while at some point formal publication of proposed legislation occurs, earlier drafts are often circulated before such publication – sort of like pre-prints of scientific papers.)

In addition to establishing publication 18 months from the earliest priority date for all currently pending and future filed patent applications, the proposed amendments would:

- result in a single, combined filing-examination-publication fee, instead of separate fees at different stages of the examination;

- eliminate the possibility of a separate claim for unjust enrichment;

- preclude certain types of amendments to the application, and

- force applicants to file an abstract identifying the “essence of the invention” as part of the application.

As will be explained below, I think that certain aspects of the proposed legislation constitute a good start, but on the whole the proposal is in need of more than a little tweaking.I also think that in some respects it doesn’t go far enough, and without some significant additions will result in a patent system that is biased toward infringers.

The most dramatic effect of the draft legislation would be the publication of all patent applications filed in Israel 18 months from the earliest priority date or, in the case of PCT national phase applications, within 3 months from national phase entry, at which point the application files would be open to the public.In exchange for this early publication, upon grant of the patent patentees would be able to sue, retroactively, for infringement of the patent during the period between publication and grant; the remedy for such infringement would be limited to reasonable royalties.

The ability to retroactively obtain damages for infringement during the period of application pendency wouldn’t be complete departure from the current law.Currently, applications are kept secret until notice of their acceptance has been published.This is followed by an opposition period; the patent isn’t granted until the opposition period passes without incident or, if an opposition has been filed, when the opposition is rejected.Applicants have no standing to bring suit for infringement prior to grant, and thus are powerless to collect damages, let alone stop infringement, that occurs during examination.However, once the patent is granted, patentees can sue retroactively for damages to the date of publication, to the extent that the claims ultimately granted were published prior to the opposition period.

Thus under the proposed amendment, the major changes from the current system would be (a) earlier publication of the application, giving the (eventual) patentee a longer retroactive window in which to collect damages for infringement, but (b) limitation of damages for such pre-grant infringement to a reasonable royalty.As is currently the case, suit could only be brought once the patent is granted, but thereafter patentees would still be able to obtain prospective enforcement of the patent in the form of injunctions, and would still be able to obtain full damages for infringement that occurred after grant.

Reasonable Royalty As Only Remedy = Compulsory License

The reasonable royalty provision of the draft legislation strikes me as a thinly-veiled form of a compulsory license.If I’m a generic drug manufacturer, it’s worth my while to infringe still-pending claims, even if I think they’re likely to eventually be granted – there’s a significant difference between what I can make selling to the four major Sickness Funds (the Israeli equivalent of HMO’s; by law everyone pays a health tax and must belong to one of the Sickness Funds) and what I would be forced to pay under a reasonable royalty scheme.Under such circumstances, if I’m a drug innovator, the way for me to ensure that my drug not be sold without my permission would be to delay the grant of marketing approval of the drug until after grant of the patent (because approval of the generic version is contingent upon grant of marketing approval to the innovator).But as a consumer, I’d prefer that new medicines enter the Israeli market sooner rather than later.Thus the draft legislation would seem to work at cross-purposes with good public policy.

Then again, in the pharma sector at least, this may be a red herring.It may be that in general, the first Israel patents covering a new drug product have already issued by the time the drug is approved for use in Israel, and that it’s more likely that follow-on applications covering formulations, new uses and the like would be the ones affected by a possible reasonable royalties scheme that operates prior to grant.If that’s so – and I don’t have statistics to confirm whether or not this is the case – then if an earlier patent was still in force, the possibility of an injunction or full damages for infringement of that patent would give copyists proper pause to consider whether or not to infringe (or to work around the earlier patent; as it is, Israel law gives third parties the right to infringe provided such infringement is done for the sake of “improving” the patented invention or “developing a new invention”, and is not done on a commercial scale).

It should be noted that on its face, the reasonable royalty provision is substantially the same as the corresponding provision in the USA, as set forth in 35 U.S.C. §154(d).However, with respect to the pharma sector, one can’t draw a clean comparison between the situation in Israel and that in the USA:

(a)Pharma patents tend to issue more quickly in the USA than in Israel.

(b)The USA has the Waxman-Hatch scheme, which compels innovators to list certain patents in the Orange Book and compels generic manufacturers to give notice when they’re going to challenge a listed patent, giving innovators an opportunity to sue and obtain an injunction or, in many cases, an automatic 30-month stay of FDA review of the generic company’s NDA.Thus as long as the innovator has at least one Orange-Book listed patent, which is invariably the case early in a product’s lifetime, there is no way for a generic manufacturer to sneak a product through the FDA without the innovator’s knowledge.In contrast, Israel has no comparable scheme.

(c)The USA has actual data exclusivity: generic manufacturers can’t even submit ANDAs within the first five years of FDA approval for a new chemical entity.Israel’s data exclusivity provisions tilt much more in favor of generic manufacturers:

(i) generic drug manufacturers may submit their generic drug applications within the first five of approval of the innovator’s product in Israel;

(ii) it is the Health Ministry (MOH) that is precluded from approving that the generic drug application during those first five years, or during the first five-and-a-half years from the first marketing approval in any WTO-member country;

(iii) MOH is only precluded from granting approval for marketing in Israel during this period; it may nevertheless grant approval for exporting during this time.

Taken together, these factors mean there is a higher likelihood that a new drug product may be approved in Israel before patent protection has been obtained than there is in the USA – if not for the local market, then for the export market.Under such circumstances, reasonable royalty damages may be insufficient to compensate the patentee.As mentioned above, I don’t know if there are statistics that attest to whether or not most new drugs approved in Israel have some form of patent protection at the time of their approval.What is clear is that the fact that the reasonable royalty remedy is good enough for the USA does not necessarily mean it is good enough for Israel.

In the high-tech arena, I suspect the difficulty would run in the opposite direction: under the proposed reasonable royalty scheme, individuals or small businesses having patentable but easily copied ideas would be at the mercy of bigger, established players.If the goal of the smaller fry is to license the technology, then without the prospect of full retroactive damages, they will have lost some leverage in their ability to negotiate a good royalty rate.Also, there is no guarantee that the “reasonable royalty” set by the court would be what the parties would actually have negotiated with the threat of full damages hanging overhead.If the goal of the small patentees is to make and sell a product, or to sell the technology, their likely recourse would be to forego patent protection altogether, since the statute would now give the big players a compulsory license.(Open question: if a big player steps in and sells infringing goods in Israel while the application is pending, then is forced to pay a reasonable royalty after the patent issues, are the downstream consumers who bought the infringing goods now immune from suit?See discussion below re: unjust enrichment.)

Foregoing patent protection, however, would only work if the small companies’ products couldn’t be reversed-engineered – assuming small companies actually got as far as manufacturing something.And without the prospect of patent protection, their leverage in negotiations with more powerful players to whom they might wish to sell the technology would tend toward zero.

It’s for the latter reason that I think it might be worthwhile to take a page from the U.S. playbook, and to allow applicants to retain the option of keeping their applications secret, if they haven’t filed corresponding applications (or more broadly, haven’t filed applications directed to substantially the same invention) in other 18-month publication jurisdictions.

Alternatively, imposing the prospect of full damages that would be retroactive to the date of publication, assuming one of the infringed claims was in the published application, would give competitors more reason to carefully consider whether or not to infringe.Ostensibly, the difficulty with such a scheme is that competitors would be left in legal limbo – which claims, if any, will issue?In practice, however, this is already what goes on in other countries, evidently without detrimental effect.In any event, sophisticated copyists are able to make reasonable assessments as to what is and is not patentable in a pending, published application.

A twist on this last idea would be to allow infringers to file a notice with the ILPTO that they are infringing while the application is still being examined, including a detailed explanation of how they are infringing the patent.This would be coupled with a bank guarantee or other surety to cover the expected reasonable royalties.Such a notice would preclude the eventual patentee from retroactively collecting full damages after grant of the patent; but the admission by the infringer would preclude the infringer from asserting non-infringement after grant of the patent with respect to the product or process specified in the notice.

Early Publication of Already-Filed Applications

The proposed amendments would apply retroactively to all still-pending applications, with the goal being publication of all pending-but-as-yet-unpublished within two months of the amendments’ coming into force.That’s not fair to those applicants who filed in Israel knowing that it does not publish applications early, and who relied on that fact in deciding to file in Israel.Yes, disclosure is the quid quo pro for the exclusivity conferred by a patent, but the timing of that disclosure is also part of the bargain; publishing already-filed applications against the wishes of the applicants amounts to changing the rules in the middle of the game.(Publishing such applications now may also create a headache for applicants who filed in Israel and in the USA with a non-publication request, knowing that Israel is a not an 18-month publication country.)

A more prudent approach would be an opt-in for applications filed before the amendments come into force: those applicants with pending applications who want their applications to publish early could request such early publication, otherwise already-filed applications would not publish early.

Precluding Claims for Unjust Enrichment

Unlike most countries, Israel has a separate statute that enables plaintiffs to recover from third parties who were unjustly enriched at plaintiffs’ expense.In principle, with respect to intellectual property, the various IP statutes themselves set the types of protections and remedies available for different types of IP, and recourse to a general unjust enrichment statute should not be available.However, during the 1990’s a trend took hold in Israeli jurisprudence whereby courts applied the general unjust enrichment statute in situations in which parties had chosen not to avail themselves of IP protection, in which such protection was actually precluded by statute (e.g. for unpatentable inventions that were already known), or in which such protection had been obtained (e.g. in the form of a patent) but had since expired.

The potential for a remedy for patent infringement apart from the patent statute has created uncertainty when it comes to assessing one’s rights to exploit another’s invention, and led in one instance to Merck suing for unjust enrichment for infringement that occurred while its patent application was being opposed.The Merck case was in fact part of the impetus for the presently proposed amendments.

Thus, hand-in-hand with providing applicants with some sort of protection during the period patent pendency, the proposed amendments would bar remedies under any other statutes for the exploitation of inventions (a) which are patentable but which are not protected by a patent in Israel, (b) for which a patent had been granted but had since lapsed or expired, or (c) which are not patentable.The preclusion would not apply to violations of fiduciary duties arising from other statutes.

This proposed change is a welcome one.It’s pity that the judiciary, which created this particular monster, did not see the error of its ways and see fit to bury its own creation without the need for a legislative fix.

Regarding the “open question” from above (viz. if a big player steps in and sells infringing goods in Israel while the application is pending, then is forced to pay a reasonable royalty after the patent issues, are the downstream consumers who bought the infringing goods now immune from suit?), this proposed amendment would evidently bar such recovery.

Let’s Use This Opportunity to Do Away With Pre-Grant Oppositions

It’s laudable that the proposed amendments would still only vest patentees with the power to bring suit once the patent has issued.But the proposed amendments don’t go far enough in that they still maintain Israel’s outdated and flawed pre-grant opposition system.Under this system, any third party can oppose the grant of the patent (without the need to identify the real party in interest).Under current rules, the mere filing of an opposition will guarantee delay of the grant of the patent by at least two years, unless the opponent withdraws the opposition, and no patent term adjustment is available for this lost time should the applicant prevail and the patent be granted.Furthermore, the fee for filing an opposition is relatively small, as are the costs imposed by the Commissioner on losing opponents.Not surprisingly, as a result there are several local companies that serially oppose their competitors’ patent applications.

Notwithstanding the ease of initiating opposition proceedings, in general opponents avoid infringing during those proceedings, as they currently face the prospect of full damages for infringement occurring during the proceedings should the application be upheld and the patent granted.Removing the prospect of full damages, and replacing it with the proposed compulsory licensing scheme, would not only increase the likelihood of infringement during opposition proceedings, it would actually encourage both the filing of additional oppositions, and the protraction of those opposition proceedings: the longer an opponent can delay the grant of the patent, the longer it can benefit from the low-cost compulsory license at reasonable royalty rates.

One option to avoid this problem, and the one that appears to me to make the most sense, would be to scrap oppositions altogether, and have patents issue upon publication of notice of their allowance.Israel adopted pre-grant oppositions from the 1949 British Patents Act, but the British abandoned the practice when they revised their statute in 1977, and it’s about time Israel did the same.(An exception could be made, perhaps, in cases of applications that weren’t published until their allowance, should the ability to maintain an application in secret be preserved under certain conditions.)

Although under my proposal, opposition proceedings would be abolished, cancellation proceedings before the Commissioner would still be available to parties who think a patent has been erroneously granted.Moreover, given the fact that applications would now be published early, interested parties would have plenty of time to track the progress of applications and decide if cancellation proceedings are warranted.Furthermore, unlike the post-grant opposition under EPO practice, which must be filed within nine months of grant, cancellation proceedings in Israel can be instituted at any time.

(I note that there is some case law from the ILPTO itself suggesting that the burden of proof is somehow different, or even rests on different shoulders, during opposition versus cancellation proceedings, but this notion is specious: in either case, the party opposing the application/patent must put forward a prima facie showing of unpatentability, and once such a showing is made, the applicant/patentee must rebut it.As there is no statutory presumption of validity under Israel law, and the only presumption of validity is the usual presumption of validity accorded to administrative action, there really is no difference between opposition and cancellation proceedings in this regard.)

Should the powers-that-be prove too wimpy to follow the lead of the British, at the very least they could amend the procedural rules for oppositions to make them more streamlined.Currently, an opponent has three months from the publication of the allowance of the application to file a Notice of Opposition, then another month thereafter to file its Statement of Arguments, and yet more time later to file written evidence; it is in no small part the time periods set forth in these rules that result in the long delay in patent grant effected by opposition proceedings.Under a system in which the substance of an application is only made public at the end of examination, there is some sense to such a time frame. But in the situation where the application file is open to the public for most of the application’s pendency, as is now proposed, there is no reason why all these steps can’t be combined, e.g. by requiring opponents to file an opposition, including arguments and written evidence, within a few months of the grant of the patent.In fact, this is just the system in place currently for cancellation actions: the party moving to cancel a patent must file its arguments and written evidence at the time it requests cancellation of the patent.

Single Fee: Bad Idea

Another feature of the proposed amendments is the introduction of a single fee for patent applications that would cover filing, examination and publication.This seems to be unwarranted.Not all applications will be examined, and those that are examined will not necessarily be allowed; why should applicants pay for steps that their applications may never undergo?The combining of the application and initial publication fee makes some sense, and in practice is what happens today; the only difference under the proposed regimen is that the initial publication would include additional details.But the separation of application and examination fees, which does not presently occur, also makes sense, as this would allow applicants to decide if they really want to pursue examination.(Of course, it would deprive the ILPTO of revenue, which is why my proposal is unlikely to be adopted.)

Limiting the Ability to Correct Applications?Limiting the ILPTO’s Ability to Request Marking of Applications?

An interesting feature of Israel patent practice follows from §§ 22 and 23 of the statute, which read as follows (my translation):

22.Any time before the acceptance of the application, the applicant may amend the specification of his application, whether in response to a notice per section 20 [i.e. an office action – DJF] or of his own volition.

23.If amendments of a substantive nature were entered in the application, the Commissioner may conclude that for purposes of sections 4, 5 and 9 [which deal respectively with novelty, inventive step and right of first filer - DJF] (1) if it is possible to distinguish between the amendments and the existing specification, that the date of the amendments is the date on which they were submitted to the ILPTO; (2) if it is not possible to distinguish between the amendments and the existing specification, that the date of the entire application is the date on which the amendments were submitted to the ILPTO.

Together, these sections give applicants the right to introduce new matter into their applications by way of amendment after the application has been filed.To the extent the new matter is distinguishable from the originally filed application, the new matter alone receives the date on which it was filed (and consequently may not be entitled to priority); to the extent the new matter is indistinguishable from the rest of the application, the entire application is accorded the later filing date.

As a result of §23, ILPTO examiners often ask applicants to label portions of their applications with the later filing date.In practice, such requests are usually made not in situations in which new matter was added after the filing date, but rather in national phase applications where new matter was added at the time the PCT application was filed, and is thus not entitled to the claimed priority date.Although imposing something of an administrative burden on applicants, the practice is quite useful for third parties parsing the patent, as it readily lets them know what material is entitled to what date.(Compare this to the situation in the USA where significant effort can go into determining what part of a CIP at the end of a long chain of CIPs is entitled to what filing date.)

The proposed amendments would do away with §23.This in itself seems unremarkable.As the explanation of the proposed amendment notes, if an applicant wishes to introduce new matter, he is free to file a new application (which will be accorded the later filing date).

Limiting Applicants’ Ability to Amend or Add Claims?

Presently, an applicant may amend a pending application for any reason, and may amend inter alia by expanding the scope of the claims and by adding claims.Under the proposed amendment, §22 of the statute would be amended to read,

22.Any time before the acceptance of the application, the applicant may amend the specification of his application, whether in response to a notice per section 20 or of his own volition, for the sake of clarification, removal of a mistake that fell in the specification or for the sake of reducing [the number of] its claims.

Several interesting points arise from this proposed amendment.The first is, just what would be considered “clarification” or “removal of a mistake”.In particular, would expansion of a previously filed claim to include disclosed but previously unclaimed subject matter be considered “clarification” or “removal of a mistake”?Or would applicants be stuck with the breadth of the claims they initially filed?

While the proposed additional wording is identical to wording that already appears in §65, which governs the amendment of the specification of an issued patent, recourse to §65 is not helpful in construing proposed amended §22, because §66 states that when amending a granted patent, the scope of the claims may not be expanded.Thus hitherto, there hasn’t been need to determine if “clarification” or “removal of a mistake” includes expansion of the scope of a previously filed claim, because such expansion was precluded by virtue of §66.Of course, the argument can be made that if §66 is necessary to tell us that expansion of the scope of the claims in a granted patent is verboten, then such expansion of scope not forbidden under §65.Nevertheless, the point hasn’t been decided before, and the possibility exists that the Commissioner or the courts could take a restrictive view regarding permissible claim amendments under the proposed amended §22.

Another point is that applicants would be statutorily barred from adding claims to their applications.But barring applicants from expanding the scope of their claims or adding claims, is both shortsighted and impractical.Anyone with any prosecution experience knows the addition or expansion of claims during prosecution happens all the time, for example to cover disclosed embodiments that weren’t previously specifically claimed, or in order to add dependent claims that cover species previously only covered by a genus claim.In order to avoid such a draconian limitation on their freedom of action, applicants with the money to so will simply front-load their applications with many claims in order to preserve for themselves the right to in essence file new claims later by “amending” earlier-filed claims.For such applicants, such front-loading will merely entail a waste of resources.Applicants with more limited resources will be forced to make choices early in prosecution about which embodiments to protect, in the process possibly foregoing protection for commercially important embodiments.

The question would also arise if under the proposed amendment, national phase applications could be amended at the time of national phase entry to include more claims than were filed in the PCT application.Indeed, since the effective filing date for national phase applications is the PCT filing date, it would seem the proposed amendment could be construed as prohibiting PCT applicants from amending their claims under PCT Articles 19 or 34 so as to include more claims than originally filed – in contravention of Israel’s obligations under the PCT.

So the proposed change to §22 impractical and unwise.But mostly, it is unwarranted.§§ 12 and 13 of the statute already provide that the specification must contain an enabling disclosure of the invention, and that the claims must reasonably arise from the description.Inasmuch as under the proposed amendment package, patent prosecution will now be transparent, there is no reason to force applicants to front-load their applications with every conceivable claim they might want later on.Applicants should be able to claim anything for which there is support in the specification; interested third parties will be able to follow the progress of the application and assess their infringement and (in)validity positions vis-à-vis those claims long before the claims are granted.

Third party observations and estoppel provisions?

Since under the proposed amendments third parties will be able to follow the progress of patent applications, the question arises if third parties should be able to comment on those applications while they are still being examined.U.S. law makes it virtually impossible for third parties to participate in the examination process once an application has been published; in contrast, the EPC allows for anonymous third party comments on pending applications.

Presently there is nothing in the Israel patent statute that explicitly permits or prohibits the participation of third parties, so a third party could assert that in the absence of a prohibition, it is allowed to file observations.However, since applications are not presently open to the public, practically speaking third parties can’t participate in the ex parte examination process.

This practical consideration will change once it becomes possible to follow the progress of applications through the ILPTO.When that happens, I can conceive of situations in which I would advise clients to anonymously file observations with the ILPTO, even in the absence of statutory provisions governing the filing of such observations.Given the ILPTO’s hyper-sensitivity to “the purity of the patents register”, it’s entirely possible that the ILPTO would pay attention to such arguments.If the ILPTO ignored those arguments, the client could have alternative arguments waiting in the wings for use in inter partes opposition or cancellation proceedings; and because the first set of arguments would have been filed anonymously, no form of estoppel would attach to the client’s ability to present the second set of arguments during the inter partes proceedings.

Which is why it would be good to include provisions in the statute that explicitly govern the participation of third parties in the examination process, and that would create estoppel so as to prevent third parties from having more than one bite at the apple.There are essentially six grounds on which a third party can challenge a patent or pending application: lack of novelty; lack of inventive step; insufficient disclosure; claims which are unclear or do not reasonable arise from the specification; failure of the applicant to comply with its duty of disclosure; and lack of applicant’s standing to apply for the patent (i.e. it was someone else, not the applicant, who was entitled to apply for the patent.)If a third party wants to challenge a pending application on any of those grounds, it should be allowed to do so, but it should then be estopped from later challenging the application or issued patent on a ground earlier raised (provided that the applicant did not amend its claims in response in order to moot the objection).So during prosecution if a third party wants to assert that a pending claim lacks novelty or inventive step, and the ILPTO determines that the claim is novel and inventive, that third party should be statutorily estopped from raising a lack of novelty of lack of inventive step challenge later, even on the basis of different prior art.

Requirement to Include an Abstract – “Essence of the Invention”

Presently applicants are not required by statute or regulation to provide an abstract of the invention. Rather, at present §26(b)(5) says that when the Commissioner publishes notice of acceptance of the application, he shall include “A description of the essence of the invention, in the view of the Commissioner”.As discussed here a few months ago, the Commissioner recently tried to shift to applicants the onus of providing an abstract; at the time, I posited that the Commissioner was not empowered to impose such a requirement.

The proposed amendments would enshrine the Commissioner’s requirement in the statute by adding §13(c), which would read,

13(c). The applicant shall attach to the specification a brief description of the essence of the invention in his application.

As explained in my earlier post, unwary applicants could find themselves sacrificing claim scope by complying with such a requirement, since the term “essence of the invention” is the same term used in §49 of the statute, which is the section that establishes that the patentee has the right to prevent others from exploiting an invention for which a patent has been granted, “whether in the manner defined in the claims or in a similar manner that includes, in view of what is defined in the claims, the essence of the invention that is the subject of the patent”.Thus, in cases where literal infringement cannot be shown, the patentee needs to demonstrate infringement of “the essence of the invention”.Applicants would therefore be remiss to put statements into the record that could be used to restrict the scope of this “essence of the invention”.Unfortunately, proposed §13(c) would force applicants to do just this.As with the restrictions on the number and amendments of claims, such a requirement would thus unfairly force applicants ab initio to potentially limit the scope of the protection to which they are entitled.

The addition of §13(c) need not undermine §49.For example, at the same time §13(c) is added, §27 could be amended to read as follows:

The description of the essence of the invention as published under §16A(a)(5) or §26(b)(5) shall not be used by a court or the Commissioner as evidentiary material when they come to interpret the specification or in any other way establish the scope of the protection conferred by the patent in any legal proceeding.

Alternatively, the words “essence of the invention” could simply be removed from proposed §13(c), so that it would instead read, for example, The applicant shall attach to the specification a brief description of the invention disclosed in his application.

As noted in an earlier posting, on December 1, 2009, the Knesset’s Constitution, Statute and Law Committee approved the imposition of a fee of 500 shekels (approximately $130 at present exchange rates) for each claim in excess of 50.Now, you’d think that even the Knesset and the Justice Ministry (which drafted the actual wording of the update) could get something as simple as this right, but noooooo – they had to word it in a way that sows confusion.To wit:

Notice of the amended regulations was published in the official state publication journal (the equivalent of the Federal Register in the USA) on December 24, 2009; the new regulations will take effect 30 days from publication, viz. on January 23, 2010.The amended regulations (namely the Second Schedule), in relevant part, read as follows:

Second Schedule

(A) 1. Upon submission of an application for patent per §11(a) of the statute, 1021 NIS

1A. Fee for submission of each claim in a patent application beginning with the 51st claim, 500 NIS * * *

This brings us to our first problem: while the revised regulations say that the fee for the first 50 claims for an application filed under §11(a) of the Patents Law is due upon filing of the application (a position necessitated by §15 of the statute, which says that an application will not be accorded a filing date until the filing fee has been paid), and that the fee for each claim in excess of 50 is 500 shekels, the amended regulations do not say when the fee for each excess claim is due.If the excess claims fees are due upon filing, then applicants will need to carefully consider how many claims to file.But if the payment of excess claims fees can be deferred until later, why not file a gazillion claims and then decide how to proceed once you’ve seen how things are progressing in the corresponding cases in Europe and the USA?

In a letter sent out on January 7, 2010, the Commissioner apparently tried to clarify this point: “The obligation to pay the fee [for excess claims] commences at the time of the filing of the patent application or at the time the specification is amended to include more than 50 claims.Such an amendment is predicated upon payment of the appropriate fee.”This implies that as soon as an application is filed with excess claims, the excess claims fees are due, even though the amended regulation does not state this.

However, the Commissioner’s letter goes on to state that “failure to pay the fee for claims 51 and up will result in delay of examination of the application until the fee is paid”, implying that the excess claims fees themselves are not due upon filing, but only when the applicant actually wants examination to proceed.Hence, writes the Commissioner, the language of the pre-examination letter that is sent to applicants shortly before substantive examination commences “will be updated…to remind the patent applicant community to pay the entirety of the fee due before the application comes up for examination.”

Thus, the Commissioner’s latter statements imply that applicants who file applications with more than 50 claims but do not pay the excess claims fees at the time of filing, then cancel the excess claims prior to the commencement of substantive examination, will not be required to pay the excess claims fees, ever (unless they re-insert the excess claims later).

Nothing like taking what should be a straightforward amendment and making it unnecessarily complicated.Presumably this matter will be clarified in the near future; personally, it seems to me that if the excess claims are cancelled prior to examination, an applicant shouldn’t have to pay for them, as the ILPTO hasn’t had to expend any extra resources examining the extra claims.(By the same token, if the excess claims were already allow by the USA or the EPO, and the applicant request allowance under §17(c), I don’t see why the applicant should have to pay excess claims fees, as the Israel examiner isn’t going to have to do any real work anyway.)

Now for the second bit of confusion: it is unclear if the new regulations apply to the national phase of PCT applications filed in Israel.How’s that?Well, amended part (A)1 of the Second Schedule, which refers to the filing fee for the first fifty claims, refers to applications filed under §11(a) of the statute.But national phase applications are filed under §48(d), not §11(a).Thus part (A)(1) clearly does not apply to national phase applications.

Moreover, part (A)7 of the Second Schedule, which sets the fee for the filing of national phase applications filed under §48(d), was not amended accordingly to refer to the first fifty claims.The failure to amend part (A)7 could thus be taken as indicating that excess claims fees are not to be imposed on national phase applications.

On the other hand, new part (A)1A does not refer to a particular section of the statute, and simply sets a “Fee for submission of each claim in a patent application beginning with the 51st claim”.Part (A)1A could thus be viewed as setting excess claims fees for national phase applications as well – although if that’s the case, why amend (A)1 at all?And why number this statement (A)1A rather than place it elsewhere, where it will be clear it’s applicable to both regular and national phase applications?

I have no doubt the ILPTO will adopt the view that excess claims fees are due for national phase applications.Any national phase applicants who would like to test this by filing an application with 51 claims and then fight the ILPTO over the charge for the 51st claim are invited to contact me – I would be willing to fight the ILPTO on this point pro bono.

On the bright side, there’s one point that doesn’t seem to be confusing: it appears from the Commissioner’s letter that the ILPTO will allow applicants who originally paid for excess claims to cancel some of those excess claims and substitute them with others.Thank goodness for small favors.